Macleods Pharmaceuticals Ltd, based in India, is a pharmaceutical company that stands out with its certifications from FDA, EDQM and WHO-GMP.
One of their notable products is BREXPIPRAZOLE, with a corresponding US DMF Number 33482.
Remarkably, this DMF maintains an Active status since its submission on January 14, 2019, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of April 01, 2019, and payment made on February 01, 2019, indicating their dedication to facilitating drug approvals, Categorized as Type II